Despite recent advances in the treatment and prevention of infectious disease, the threat to world health continues to grow. The spread of new zoonotic viral strains like avian influenza and the emergence of antibiotic resistant forms of long established pathogens such E. coli underscores the danger from ever evolving pathogens. In this era of expanding infectious threats, the development of novel, effective and practical vaccine adjuvants has lagged considerably. Adjuvants can be classified as 1) delivery systems or 2) immune potentiators on the basis of their mechanism of action. Immune potentiators, such as cytokines, activate the immune system directly. Delivery system adjuvants serve to concentrate or target vaccine antigens to APCs or to co-localize antigens and immune potentiators. TherapyX, Inc. uses the proprietary phase inversion nanoencapsulation (PIN) technology to create biological adjuvants that combine the properties of an immune potentiator and a delivery system. To this end, TherapyX, Inc. has developed a particulate-based, sustained-release cytokine adjuvant formulation that can induce highly effective TH1 type T-cell and antibody responses. Proof of principle for the efficacy of this formulation has been demonstrated in numerous tumor vaccine studies. More recently, TherapyX, Inc. developed a second generation nanoparticle formulation (TPX-506) that is biologically stable at room temperature for at least one year; making this an ideal adjuvant for vaccination against infectious disease in underdeveloped areas of the world. This application will test the efficacy of TPX-506 against extraintestinal pathogenic Escherichia coli (ExPEC) in a mouse urinary tract infection model. The diversity, frequency, potential severity, and economic impact of extraintestinal infections due to E. coli are as great as for any bacterial infection. With no other current vaccines available, the successful production this vaccine will address a significant gap in the bacterial prophylaxis market. [unreadable] [unreadable] PUBLIC HEALTH RELEVANCE - PROJECT NARRATIVE: The diversity, frequency, potential severity, and economic impact of extraintestinal infections due to E. coli are as great as for any bacterial infection. This application will test the efficacy of the TPX-506 vaccine against extraintestinal pathogenic Escherichia coli (ExPEC) infection. With no other current vaccines available, the successful production this vaccine will address a significant gap in the bacterial prophylaxis market. [unreadable] [unreadable] [unreadable]